AmpliVue Trichomonas Assay

Q: What is the product code of K143329?

The FDA product code is OUY – Trichomonas Vaginalis Nucleic Acid Amplification Test System, a Class II (moderate risk) device regulated under 21 CFR 866.3860.

FDA 510(k) K143329 · Quidel Corporation

Substantially Equivalent

510(k) numberK143329

Submission

Device name: AmpliVue Trichomonas Assay
Applicant: Quidel Corporation
Athens, OH, US
Received: November 20, 2014
Decision date: March 17, 2015
Decision: Substantially Equivalent (SESE)
Type: Traditional 510(k)
Summary: 510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code: OUY – Trichomonas Vaginalis Nucleic Acid Amplification Test System
Device class: Class II (moderate risk)
Regulation: 21 CFR 866.3860
Specialty: Immunology

In vitro nucleic acid amplification test for the qualitative detection of ribosomal rna from trichomonas vaginalis as an aid in the diagnosis of trichomoniasis from vaginal, cervical, urogenital and gynecological specimens from symptomatic patients

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K231316	Aptima Trichomonas vaginalis AssayOUY · Traditional	Hologic, Inc.	11/06/2023SE
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K151589	BD Max Ct/Gc/Tv, BD Max InstrumentOUY · Traditional	Becton, Dickinson and Company	09/06/2016SE
K161619	Xpert TV, Xpert Urine Specimen Collection Kit, GeneXpert Dx Systems (GX-I, GX-II, GX-IV…OUY · Traditional	Cepheid	08/29/2016SE
K161182	Solana Trichomonas AssayOUY · Traditional	Quidel Corporation	08/15/2016SE
K151565	Xpert® TV Assay on the Cepheid GeneXpert Instrument Systems (GeneXpert Dx, GeneXpert…OUY · Traditional	Cepheid	10/16/2015SE
K130268	BD Probetec Trichomonas Vaginalis (TV) QX Amplified DNA AssayOUY · Traditional	Becton, Dickinson & CO	08/23/2013SE
K122062	Aptima Trichomonas Vaginalis Assay - PantherOUY · Traditional	Gen-Probe, Inc.	01/09/2013SE

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Questions and answers

When was AmpliVue Trichomonas Assay cleared by the FDA?

AmpliVue Trichomonas Assay (K143329) received a 510(k) decision of Substantially Equivalent on March 17, 2015, 117 days after the submission was received.

What is the product code of K143329?

The FDA product code is OUY – Trichomonas Vaginalis Nucleic Acid Amplification Test System, a Class II (moderate risk) device regulated under 21 CFR 866.3860.